Bengaluru, May 14, 2016: Pharmaceutical industry, a world where health is valued more before the sickness comes. Since ages the Pharma world is giving its patients medicines that can be a reason for their healthy living. With infinite research & development, medical formulations and patents, the industry has achieved an incremental increase in their business as well a pathway of expansion. Clinical Trials is one of the most important practice conducted in this industry. Designed to answer specific questions, Clinical trials are experiments done to determine the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. They are conducted only after they have received health authority. The authorities are responsible for deciding the risk/benefit ratio of the trial.Depending on product type and development stage, investigators initially enroll volunteers or patients into small studies, and subsequently conduct progressively larger scale studies. A clinical trial is further on a kick-start when the concerned cost is completely incurred. From patients to research material, designing to chemical formulation, communication to investigator training, and certain other necessities should be available for conducting a successful trial. The sponsors for such trials can either be a private NGO or Government. Thus, Clinical trials vary in size and cost. There are different types of trials conducted to detect and determine specific issues and results. Prevention Trials, Screening Trials, Diagnostic Trials, are few examples of different clinical trials that are conducted. Every kind of trial furthergoes through four phasesinorder to evaluate certain specification of the medical formulation. Patient recruitment, Patient engagement and Patient retention are most important stages of a clinical trial.
Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators (if different from the sponsor), the various IRBs that supervise the study, and (in some cases, if the study involves a marketable drug or device), the regulatory agency for the country where the drug or device will be sold.
For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures.
Performed by the patient recruitment service provider, patient recruitment is about hosting clinical activities that range from protocol development and study feasibility to site selection on, from first patient till the last one present. The world of clinical trials has issues with patient recruitment and enrolment which have gradually become the primary causes for missing clinical trial timelines. Recruiting a patient for a certain trial does not only become difficult but also expensive. Most of the companies go beyond their planned deadline for a clinical trial. It becomes difficult to perform every activity on time unless the patient is a volunteer. But as it is said necessity is the mother of invention, the sponsors and the investigators look for all the means by which there can be an increase in patient recruitment rate. The primary ways to promote patients for attending clinical trials is the Pull and Push method. The ‘Pull’ing of patients into clinical trials is majorly done by physicians who are the principal investigator of the concerned trial as well. Whereas, the ‘Push’ method promotes patient recruitment by creating awareness. Pushing patients into trials is done through the media outlets like television, mass mailing system and the most popular social media. In addition, outside services like patient networks and patient recruitment companies identify patients and attempt to push them towards clinical trials. It is also proven that inspite of all the recruitment methods the patients aren’t active which means that a good percentage of patients are being pulled for the trials.
It has been suggested that clinical trial participants be considered to be performing ‘experimental’ or ‘clinical labour’. Re-classifying clinical trials as labour is supported by the fact that information gained from clinical trials contributes to biomedical knowledge, and thus increases the profits of pharmaceutical companies. The labour performed by those participants in clinical trials includes the provision of tissue samples and information, the performance of other tasks, such as adhering to a special diet, or (in the case of phase I trials particularly) exposing themselves to risk.The participants in exchange are offered potential access to medical treatment. For some, this may be a treatment with the potential to succeed where other treatments have failed. For other individuals, particularly those situated in countries such as China or India, they may be given access to healthcare which they otherwise would be unable to afford, for the duration of the trial.
The fall in this stage of clinical trial can further be raised by improving their site success. Keeping the patients engaged to the clinical site with the ‘Word of Mouth’ advertising strategy has always been marked as a successful way of dealing with the approval andThis would further cater their strategies by having resources available on time.
Patients play a key role in determining your product’s commercial success. It is indeed very essential to keep the patients engaged and actively involved with every trial on your schedule. In today’s highly networked, digital healthcare environment building up a connection with patients becomes very difficult. Drug developers can further create interactive connections in the crowd by having a customized approach with efficient and effective methods. A digital solution for a digital oriented world works better than the old school strategies. Direct-to-patient connection through digital platform would create awareness about clinical trials at a wider reach. By bridging the communication gap, the clinical trial managers and sponsors can actively reach out to patients to enrol them with different healthcare communities and trials. To keep the patients engaged, the pharmaceutical company can further form Patients communities. A strong and direct communication with the community would alter the delay of the scheduled trials. The clinical trials will further meet their deadlines if the patients are actively engaged with the activity. Patient engagement will not only help people make informed health care decisions but will also bring an improvement health care delivery. Acceleration in the positive outcome of the clinical trials can be marked by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers and the broader health care community. Healthy is an outfit that makes each and every patient better and comfortable.
Patient Recruitment and Patient Engagement play important role in clinical trial but at times are unable to retain their importance when the process of Patient Retention is overlooked. For clinical trials to adhere the timeline it is very essentials for the sites to retain the patients. Intense communication and intervention helps in keeping the patients in loop with on-going trials as well as the upcoming ones. A personalized reminder to the patient will also cater their interest in staying connected with your site. Mr. Ketan Zota, director of Zota Healthcare Limited says, “It becomes very necessary for a pharmaceutical firm to have its patients retained for a certain period of time. More than the firm its the patient that gives you an appropriate feedback on the medical formulations that the firm has created.” Nothing in the pharmaceutical cycle is an easy task. Patients further help in making tasks easier by providing feedbacks and volunteering for the upcoming trials. Educate the patients about the complex procedures that exist with short tutorials. Treating clinical trial participants well will help the firm retain the participant’s regularity.
“Attention is good for morale,” maintaining an active flow and continuity of this process for every clinical trial will not only mark the growth of the Pharmaceutical Industry but will also help people make informed and better healthcare decisions.
Corporate Comm India (CCI Newswire)
